MAUDE Adverse Event Report: HARMAR MOBILITY LLC PINNACLE SL300; Powered stairway chair lift

Model Number	SL300
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pinnacle sl300 chassis was returned on 02/04/2026 and evaluated by harmar engineering and quality subject matter experts.It was determined that the end cap screws were likely either overtightened and stripped by the installer, or that the end cap was overtightened in production, or damaged during handling and installation.A capa has been opened to further investigate the issue and evaluate appropriate corrective and preventive actions, if applicable.Should additional information become available, a supplemental report will be submitted as necessary in accordance with 21 cfr 803.56.This report does not constitute an admission or conclusion by the manufacturer or fda that the manufacturer or its device caused or contributed to the event described in this report.
Event or Problem Description
It was reported that when the end user was riding the pinnacle sl300 downstairs, the track's end cap fell off and seveal pieces of the gear rack slide out towards the bottom of the staircase.The reporter stated that the end user continued to descend a few feet and hit her wrist against the armrest causing the bruising.The sl300 unit was installed in (b)(6) 2025.

• Brand Name: PINNACLE SL300
• Common Device Name: Powered stairway chair lift
• Manufacturer (Section D): HARMAR MOBILITY LLC; 1204 s dean ave; raymore MO 64083
• Manufacturer Contact: donald rea ; 1204 s dean ave; raymore, MO 64083 ; 8167442415
• MDR Report Key: 24381533
• Report Number: 3004153586-2026-00001
• Device Sequence Number: 16081580
• Product Code: PCD
• UDI-Device Identifier: 00817650026188
• UDI-Public: 00817650026188
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SL300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female